ClinicalTrials.gov record NCT07336394
Precision Diagnosis and Risk Stratification of Rare Cardiomyopathies Based on Novel Cardiac Magnetic Resonance Techniques
Multimodality Imaging (Cardiovascular Magnetic Resonance Imaging, Echocardiography, and Nuclear Medicine Imaging) in the Screening, Diagnosis and Risk Stratification of Rare Cardiomyopathies - a Multicenter Study
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study uses advanced cardiac imaging, especially novel cardiac magnetic resonance (CMR) techniques, to study rare cardiomyopathies. It aims to collect imaging biomarkers and follow clinical outcomes over time to learn how imaging relates to diagnosis and future risk. Participation involves imaging assessments and long-term clinical follow-up; the study plans multi-year follow-up (target duration 10 years).
What it is studying. Whether novel imaging biomarkers—for example T1/T2 mapping, extracellular volume (ECV), feature-tracking strain, and refined late gadolinium enhancement (LGE) patterns—can identify features of rare cardiomyopathies and be associated with outcomes such as death, heart transplantation, heart-failure hospitalization, and device implantation.
What the researchers hope to learn. Validate and apply novel CMR imaging biomarkers (T1/T2 mapping, ECV, feature-tracking strain, LGE pattern refinement) to: improve diagnostic precision for rare cardiomyopathies; provide better risk stratification linked to outcomes (all-cause and cardiovascular death, transplantation, hospitalizations, device implantation); and generate data to inform clinical decision-making and future research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
What is this study about? This research is focused on improving the care for people with rare heart muscle diseases, known as rare cardiomyopathies. These are uncommon conditions where the heart muscle becomes stiff, thick, or enlarged, making it harder for the heart to pump blood. Because they are rare, they can be difficult to diagnose and manage. The investigators are testing new, advanced ways of using a heart scan called a Cardiac Magnetic Resonance (CMR). Participants can think of a CMR as a very powerful camera that takes detailed pictures of their heart without using radiation. What is the study trying to learn? Better Diagnosis: The investigators want to see if these new scanning techniques can help us identify these rare heart conditions more clearly and accurately. This means patients could get a correct diagnosis sooner. Personalized Risk Assessment: The investigators want to see if the scan can help us understand the future risk for each patient better. For example, can it help predict which patients are more likely to have a heart rhythm problem or need specific treatments? This helps doctors create a care plan that is tailored just for participants. What does this mean for participants? If participants choose to take part, they will undergo a CMR scan that uses these new techniques. By participating, they will be helping us find better ways to diagnose and care for people with their condition in the future. The goal is to turn uncertainty into clearer, more personalized information for patients and families.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients who have received a cardiac magnetic resonance examination since 2010 and have a suspicion of rare cardiomyopathy.
Exclusion criteria
- Severe arrhythmia;
- Severe primary cardiac valvular disease;
- Refuse to participate in the study.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Study Objective: This study aims to validate and apply novel Cardiac Magnetic Resonance (CMR) imaging biomarkers to improve the diagnostic precision and risk stratification of rare cardiomyopathies (e.g., cardiac amyloidosis, Fabry disease, Danon disease, Noonan disease). Clinical Problem: Rare cardiomyopathies are often challenging to diagnose due to overlapping phenotypic features with more common disorders and their heterogeneous presentation. Current risk stratification tools are imperfect, leading to delays in diagnosis and suboptimal timing of interventions. Methodology \& Innovation: The study will employ advanced CMR techniques that move beyond standard volumetric and functional assessment. This includes, but is not limited to: T1/T2 Mapping: For quantitative tissue characterization to detect diffuse fibrosis or edema without contrast. Extracellular Volume (ECV) Fraction: To quantify the expansion of the extracellular space, a key marker in amyloidosis and other infiltrative diseases. Feature Tracking Strain Analysis: To assess subtle myocardial deformation abnormalities that precede a decline in ejection fraction. Late Gadolinium Enhancement (LGE) Pattern Refinement: For more precise characterization of scar and infiltration patterns. Potential Impact for Clinical Practice: Referral \& Diagnosis: This research could provide more definitive, non-invasive diagnostic data, streamlining the referral pathway to specialist centers and reducing diagnostic odysseys for patients. Risk Stratification: The novel biomarkers investigated have the potential to offer superior prognostic value compared to current clinical models. This can aid in identifying high-risk patients earlier, guiding decisions regarding device therapy (ICD) initiation or referral for advanced therapies. Management: By providing a more detailed "tissue phenotype," the findings could help monitor disease progression and response to emerging targeted therapies more sensitively.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
The registry requires that you have already had a cardiac magnetic resonance (CMR) examination since 2010 to be eligible; the record does not say the study performs that prior exam. As a participant you will undergo CMR using the novel imaging techniques the study describes (for example T1/T2 mapping, extracellular volume measures, feature-tracking strain analysis, and refined late gadolinium enhancement assessment). The study uses multimodality imaging approaches and may include echocardiography and nuclear medicine imaging as part of the diagnostic and risk-stratification work. Participants will be followed over time (the registry's target duration is 10 years) for clinical outcomes such as all-cause and cardiovascular death, heart transplantation, hospitalizations for heart failure, and device implantations.
How the study is structured. A prospective, observational case-control study that uses multimodality cardiac imaging (notably advanced CMR techniques, alongside echocardiography and nuclear imaging) and then follows participants' clinical outcomes over years. Imaging biomarkers will be measured and compared across groups, and clinical events will be tracked to assess links between imaging findings and later outcomes. The registry lists a target duration of 10 years and outcome time frames spanning about 2–15 years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on ATTRv amyloidosis
This trial is also listed on this site under Fabry disease and wild-type ATTR amyloidosis.
Important dates
- Study start
- Jan 1, 2010
- Primary completion
- Dec 30, 2028 (estimated)
- Study completion
- Dec 30, 2030 (estimated)
- Target enrollment
- 1000 participants (estimated)
- Last updated on registry
- Jan 21, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Principal investigator
- Minjie Lu, Director of Magnetic Resonance Imaging
Chinese Academy of Medical Sciences, Fuwai Hospital - Collaborators
- Peking Union Medical College Hospital
- Beijing Anzhen Hospital
- The First Affiliated Hospital with Nanjing Medical University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Minjie Lu MD, PhD 📞 01088396941 ✉ coolkan@163.com
Participating sites (1)
- Fuwai HospitalRecruiting
Beijing, 100037 · China
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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